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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
1998
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(R)-quinuclidin-3-ol
EC Number:
246-857-6
EC Name:
(R)-quinuclidin-3-ol
Cas Number:
25333-42-0
Molecular formula:
C7H13NO
IUPAC Name:
(3R)-1-azabicyclo[2.2.2]octan-3-ol
Test material form:
solid: crystalline

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Germany
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: at least 1.0 kg
- Housing: Individually in labelled cages with perforated floors
- Diet (e.g. ad libitum): Standard Laboratory rabbit diet, approx. 100 g per day. Pressed hay provided twice per week
- Water (e.g. ad libitum): Free access to tap-water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12h dark/12h light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.4mL
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure: 150sq.cm
- Type of wrap if used: Metalline patch 2 x 3 cm. Patch mounted on micropore tape wrapped with Coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) hours

SCORING SYSTEM:
- Method of calculation: using numerical scoring system in table 1 below

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Max. score:
4
Reversibility:
not reversible
Remarks on result:
not determinable
Remarks:
Not scored due to eschar formation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Max. score:
4
Remarks on result:
not determinable
Remarks:
Not scored due to eschar formation
Irritant / corrosive response data:
On 25% of the treated surface, black discolouration of the skin (a sign of necrosis) was present after 1 and 24 hours, resulting in eschar formation. A thick black scab was noted after 72 hours. Erythema score 4 was indcated for the aforementioned skin effects. Reactions seen in the remaining skin area (75%) resulted in erythema scores between well defined and moderate to severe erythema. Scoring of oedema was not possible after 48 and 72 hours due to eschar formation and/scab formation.
Other effects:
The animal was sacrified for humane reasons after 72 hours based on the severity of the skin effects, and no other animals treated.

No staining of the treated skin by the test substance was observed.

No symptoms of systemic toxicity were observed in the animal during the test period.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Remarks:
Not possible to sub-categorise based on data available
Conclusions:
This substance is corrosive to skin under the conditions of the test.